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NCT05067218 Clinical Trial

Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

Anesthesia Clinical Trial

Official title:
Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05067218
Other study ID # Buzzy device in Children.
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2021
Est. completion date November 15, 2022

Study information
Verified date September 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

Description:

The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 12
Est. completion date November 15, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria: - Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour. - Medically fit children (ASA I, II). - Children mentally capable of communication. - Children aged 6-11 years. - First dental visit. - Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment. Exclusion Criteria: - Children with a behavioral management problem. - Children with known allergy to local anesthetic agents. - Parental refusal for participation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• buzzy device
bee shaped with wings could be frozen.
Other:
• Conventinal anasthesia
normal technique of injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Other Child's behavior during local anesthesia injection. FLACC scale one hour
Primary Pain perception during LA injection by wong baker scale one hour
Secondary Heart rate during injection of local anesthesia. pulse oximeter one hour
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